DECRETO 18 luglio 2012 - Aggiornamento degli allegati al decreto legislativo 8 settembre 2000, n. 332, recante recepimento della direttiva 98/79/CE relativa ai dispositivi medico-diagnostici in vitro, in attuazione della direttiva della Commissione europea 2011/100/UE. (12A10561)
IL MINISTRO DELLA SALUTE
Visto il decreto legislativo 8 settembre 2000, n. 332, e successive modificazioni, recante: «Attuazione della direttiva 98/79/CE del Parlamento europeo e del Consiglio relativa ai dispositivi medico-diagnostici in vitro», ed in particolare l'allegato II;
Vista la direttiva 2011/100/UE della Commissione europea, del 20 dicembre 2011, che modifica la direttiva 98/79/CE del Parlamento europeo e del Consiglio relativa ai dispositivi medico-diagnostici in vitro, inserendo nell'elenco A dell'allegato II il test di screening ematico, diagnosi e conferma della malattia di Creutzfeldt-Jakob (vMCJ);
Vista la legge 4 febbraio 2005, n. 11, recante: «Norme generali sulla partecipazione dell'Italia al processo normativo dell'Unione europea e sulle procedure di esecuzione degli obblighi comunitari», ed in particolare l'art. 13, comma 1, che prevede che «alle norme comunitarie non autonomamente applicabili, che modificano modalita' esecutive e caratteristiche di ordine tecnico di direttive gia' recepite nell'ordinamento nazionale, e' data attuazione, nelle materie di cui all'art. 117, secondo comma, della Costituzione, con decreto del Ministro competente per materia, che ne da' tempestiva comunicazione alla Presidenza del Consiglio dei Ministri - Dipartimento per le politiche comunitarie»;
Tenuto conto che la direttiva 2011/100/UE apporta solo modifiche di ordine tecnico ed applicative alla vigente normativa in materia di dispositivi diagnostici in vitro;
Decreta:
Art. 1
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All'allegato II, elenco A, del decreto legislativo 8 settembre 2000, n. 332, e' apportata la modifica riportata nell'allegato del presente decreto.
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Il presente decreto entra in vigore il giorno successivo a quello della sua pubblicazione nella Gazzetta Ufficiale della Repubblica italiana.
Il...
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